Alexander Lowe Email & Phone Number

Minneapolis, MN, US

Minneapolis, MN, US

• An ISO 9001 certified, ISO 13485 certified environment.
• Senior Manufacturing Engineer on project team moving legacy production lines to contract manufacturer.○ Work with sending site to identify gaps in current processes, documentation, and validation. Identifying risks to.
• Support for contract manufacturer after line transfer complete.○ Review production metrics to identify targets for scrap reduction, risk mitigation, or process improvements.○ Review field complaints with design owner..

• An ISO 9001 and ISO 13485 certified environment.
• Acted as the lead Sequel engineer working with a primary customer launching a redesigned product.o Created work instructions for all associated assembly processes.o Lead the effort with customer engineers to generate.
• Maintenance of the documentation system.○ Reviewing customer Engineering Change Orders (ECO/ECN/CHO), identifying errors or missing information, and working with the customers to resolve those issues. Processing these.
• Maintenance of the Expandable ERP system.○ Reviewing ERP records for accuracy and completion as part of regular ECN implementation.○ Leading effort to transition company over to full utilization of the current ERP.
• Leading effort to transition SSP from a paper documentation system to an electronic PLM.
• General support of operationso Creation of support documentation for safety, equipment usage, etc…o Translating line technician feedback into fixture designs to improve efficiency and reduce opportunities for mistakes.

• An ISO 9001 certified, ISO 13485 compliant environment.
• Developed and validated scaled up manufacturing processes for critical materials, such as conjugated micro-particles and modified proteins.
• Facilitated transfer of products from R&D to manufacturing.○ Generation of product cost estimates to aid development in meeting cost targets○ Tracked documentation readiness for individual projects and driving.
• Generated customized Excel workbooks enhanced with VBA macros to generate analysis and reports for troubleshooting efforts, capacity planning (DFT/Lean), and documentation and process gap closure.
• Interfaced with SAP ERP system to extract data for analysis and performed maintenance on BOMs and routings. Responsible for coordinating the effort to update this information in SAP as part of the annual cost roll.
• Designed new packaging to eliminate a major product defect that cost millions of dollars in product replacements, and reduced shipping costs by hundreds of thousands of dollars annually, as part of a design for.

• Original member of the start-up manufacturing team.
• Worked with R&D designing and executing experiments for product development.
• Authored the original manufacturing SOPs, tailoring the first generation R&D protocols to fit a manufacturing environment.
• Development of new and scaled-up production processes.
• Designed, planned and executed validations of new manufacturing processes, materials and facilities.
• Assisted in bringing new products on-line. Developed production processes and appropriate specifications. Generated SOP’s, specification documentation, bills of material, and contributed to the design of the product.